HW 7
Go to:
http://www.fda.gov/default.htm
o Under “Recalls and Alerts”, click on “Warning Letters” o Under “Ways to View/Browse Warning Letters”, type GLP in the search box. Click on “Search”.
o Examine the table showing the “Warning Letters Search Results”. What are the different centers (3) in the FDA that that issue GLP warning letters?
Go to:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm222775.htm
Summarize and comment on specific GLP violations by SNBL in the warning letter (specific actions/activities or lack thereof).
o From the first paragraph, the inspections are conducted as part of which FDA program?
o Which personnel has “primary responsibility to establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical safety data for FDA submission”?
o Within how many business days of the Warning Letter receipt is SNBL supposed to respond to the FDA issues?
NB: We do not resell papers. Upon ordering, we do an original paper exclusively for you.
Do you need a similar assignment done from scratch? We have qualified writers to help you. We assure you an A+ quality paper that is free from plagiarism. Order now for an Amazing Discount! Use Discount Code "save15" for a 15% Discount!
Request essay helpYou can trust us for this and even for your future projects